Compilation of a Japanese Device Master File - Seihin Hyojun Sho
The creation of a Device Master File, called a "Seihin Hyojun Sho," is an essential step in obtaining approval to sell a medical device in Japan. The Seihin Hyojun Sho is very similar to a European Technical File, but contains additional information that addresses the specific labeling, packaging and MAH requirements imposed by Japan's Pharmaceutical Affairs Law (JPAL).
If you already sell your device in Europe and seek approval in Japan, Emergo Group can help modify your existing Technical File so it can be used for your Device Master File in Japan.
